Rules & Regs: FDA tough on FCNs

Until recently, the agency showed some flexibility in enforcing the tight time frame, usually allowing a several-day grace period as long as the information submitted in response to its questions did not necessitate a significant amount of study by FDA. Now, however, FDA appears to be sticking more rigidly to the 10-day requirement. If the information is not submitted on time, the agency will restart the 120-day review period from the date the requested information is submitted.